Clotrimazole Topical Solution Usp, 1%

Prescription

Nomes comerciais: Clotrimazole Topical Solution USP, 1%

Forma Farmacêutica

Topical

Via de Administração

TOPICAL

Fabricante

ScieGen Pharmaceuticals, Inc.

About This Medication

DESCRIPTION Clotrimazole Topical Solution USP, 1% contains 10 mg clotrimazole USP, a synthetic antifungal agent having the chemical name 1-(o-Chloro-α,α-diphenylbenzyl) imidazole with the following structural formula: Molecular Formula C 22 H 17 ClN 2 Molecular Weight 344.85 Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol, and chloroform. Each mL of Clotrimazole Topical Solution, USP 1% contains 10 mg clotrimazole USP in a nonaqueous vehicle of polyethylene glycol 400. Chemical Structure

Princípios Ativos

Ingrediente	Concentração
Clotrimazole	-

Indicações e Uso

INDICATIONS AND USAGE Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton fluoccosum , and Microsporum canis .

Posologia e Administração

DOSAGE AND ADMINISTRATION Gently massage sufficient Clotrimazole Topical Solution, USP 1% into the affected and surrounding skin areas twice a day, in the morning and evening. Clinical improvement, with relief of pruritus, usually occurs within the first week of treatment with Clotrimazole Topical Solution, USP 1%. If the patient shows no clinical improvement after 4 weeks of treatment with Clotrimazole Topical Solution, USP 1% the diagnosis should be reviewed.

Side Effects Overview

ADVERSE REACTIONS The following adverse reactions have been reported in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritius, urticaria, burning, and general irritation of the skin. To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc. at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Advertências e Precauções

WARNINGS Clotrimazole Topical Solution is not for ophthalmic use.

Contraindicações

CONTRAINDICATIONS Topical antifungal agents are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Frequently Asked Questions

INDICATIONS AND USAGE Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton fluoccosum , and Microsporum canis .

DOSAGE AND ADMINISTRATION Gently massage sufficient Clotrimazole Topical Solution, USP 1% into the affected and surrounding skin areas twice a day, in the morning and evening. Clinical improvement, with relief of pruritus, usually occurs within the first week of treatment with Clotrimazole Topical Solution, USP 1%. If the patient shows no clinical improvement after 4 weeks of treatment with Clotrimazole Topical Solution, USP 1% the diagnosis should be reviewed.

WARNINGS Clotrimazole Topical Solution is not for ophthalmic use.

CONTRAINDICATIONS Topical antifungal agents are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Clotrimazole Topical Solution Usp, 1% is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

References & Data Sources

• DailyMed — Clotrimazole Topical Solution Usp, 1% drug label (National Library of Medicine)
• openFDA — Clotrimazole Topical Solution Usp, 1% label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 309370 (NLM Normalized Drug Names)
• NDC Directory — Clotrimazole Topical Solution Usp, 1% (FDA National Drug Code)

Aviso Médico

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Sempre busque o aconselhamento do seu médico ou outro profissional de saúde qualificado para quaisquer dúvidas que você possa ter sobre uma condição médica ou medicamento.

Fontes de dados: DailyMed (NLM), openFDA, MFDS